UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051224 |
|---|---|
| Receipt number | R000058403 |
| Scientific Title | Treatment Preferences for Patients with Esophageal Cancer in Japan |
| Date of disclosure of the study information | 2023/06/12 |
| Last modified on | 2025/08/08 13:38:21 |
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Basic information
Public title
Treatment Preferences for Patients with Esophageal Cancer in Japan
Acronym
PPEC Study
Scientific Title
Treatment Preferences for Patients with Esophageal Cancer in Japan
Scientific Title:Acronym
PPEC Study
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarify what esophageal cancer patient value as treatment strategies
Basic objectives2
Others
Basic objectives -Others
To clarify the profile of drugs emphasized by patients with esophageal cancer as treatment methods and the trade-offs related to efficacy and safety in esophageal cancer treatment
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
DCE-based relative importance of attributes in patients with esophageal cancer
Key secondary outcomes
Trade-offs between DCE-based attributes and subgroup analyses based on patient and clinical characteristics in patients with esophageal cancer
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Signed informed consent
2. Age18 years or more
3.Self reported esophageal cancer
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Matsumoto |
Organization
Ono Pharmaceutical Co., Ltd.
Division name
Oncology Medical , Medical Affairs
Zip code
103-0023
Address
9-11, Nihonbashi-Honcho 4-Chome Chuo-ku, Tokyo
TEL
03-5640-3711
hi.matsumoto@ono-pharma.com
Public contact
Name of contact person
| 1st name | Tshioaki |
| Middle name | |
| Last name | Murofushi |
Organization
INTAGE Healthcare, Inc
Division name
Market Access, Marketing Insight
Zip code
101-0062
Address
Ochanomizu Sola City 13F Kanda Surugadai 4-6 Chiyoda-ku, Tokyo
TEL
03-5294-8393
Homepage URL
toshiaki.murofushi@intage.com
Sponsor or person
Institute
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb K.K.
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ono Pharmaceutical Co.,ltd.
Address
8-2,Kyuutaromachi1-chome,Chuo-ku, osaka-shi,Osaka
Tel
06-6263-5670
n.nishiwaki@ono-pharma.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10388-025-01143-6
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10388-025-01143-6
Number of participants that the trial has enrolled
149
Results
Respondents placed the highest relative importance on 1-year overall survival (OS; Relative Attribute Importance [RAI] 31.4%
),followed by hospitalization/dosing time (RAI 27.3%).Safety attributes, including immune-related adverse events, had relatively little influence (RAI or lower 7.5%). Patients were willing to trade off 17.4% of 1-year OS by changing from hospitalizations and long dosing time to no hospitalization and short dosing times.
Results date posted
| 2025 | Year | 08 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 149 respondents who answered the survey between August 28 and September 1, 2023, were included in the analysis. Among them, 134 (89.9%) were male, and 94 (63.1%) were aged 65 years or older. In total, 101 patients (67.8%) were attending medical facilities for EC treatment, 37 (24.8%) had hypertension, and 28 (18.8%) were receiving treatment for head and neck cancer in addition to EC. The most common histological types of EC were squamous cell carcinoma (68.5%) and adenocarcinoma (10.7%). Stage I EC was the most common (34.2% of patients). Regarding treatment history, endoscopic resection was the most frequently reported (62.4%), and 40.3% of patients had received drug therapy. Among the 60 patients (40.3%) with a history of drug therapy, treatments included cytotoxic anticancer agents (37/60, 61.7%) and ICIs (10/60, 16.7%).
Participant flow
Patients with EC who were registered in a patient panel were recruited and responded through a self-administered web-based questionnaire developed by INTAGE Healthcare (IHC).
Adverse events
none
Outcome measures
The primary endpoint was the relative attribute importance (RAI). In addition, trade-offs between attributes and subgroup analyses based on patient characteristics and clinical characteristics were also conducted.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 06 | Month | 01 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058403
